NCT03753152

Brief Summary

This clinical investigation is a randomized, evaluator-blind, active controlled, noninferiority study to evaluate the effectiveness and safety of Neuramis® Deep Lidocaine when compared with YVOIRE® Volume Plus.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
370

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 2, 2018

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 22, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 26, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 2, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 16, 2019

Completed
Last Updated

July 28, 2020

Status Verified

July 1, 2020

Enrollment Period

1 year

First QC Date

November 22, 2018

Last Update Submit

July 27, 2020

Conditions

Nasolabial Folds

Outcome Measures

Primary Outcomes (1)

  • WSRS improvement rate at Week 24

    WSRS improvement rate at Week 24

    Week 24

Secondary Outcomes (3)

  • Change of WSRS from Week 4, 12, 24, 36, and 52

    Week 4, 12, 24, 36, and 52

  • WSRS improvement rate on Week 4, 12, 36, and 52

    Week 4, 12, 36, and 52

  • GAIS improvement rate on Week 4, 12, 24, 36, and 52

    Week 4, 12, 24, 36, and 52

Study Arms (2)

Investigational medical device

EXPERIMENTAL

Neuramis® Deep Lidocaine

Device: experimental

Comparator device

ACTIVE COMPARATOR

YVOIRE® Volume Plus

Device: comparator

Interventions

experimentalDEVICE

Neuramis® Deep Lidocaine

Investigational medical device
comparatorDEVICE

YVOIRE® Volume Plus

Comparator device

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female, 18 to 75 years of age.
  • Subjects who desire correction of bilateral NLFs that are rated as 3 or 4 points on the WSRS.

You may not qualify if:

  • Subjects who have received anticoagulation, antiplatelet, or thrombolytic medications, anti inflammatory medications.
  • Subjects who had soft tissue augmentation, medium or deep peeling, or dermal photorejuvenation on the lower inferior orbital rim for wrinkle correction.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HuaShan hospital Fudan University

Shanghai, China

Location

Study Officials

  • Jinhua XU

    Huashan Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2018

First Posted

November 26, 2018

Study Start

April 2, 2018

Primary Completion

April 2, 2019

Study Completion

October 16, 2019

Last Updated

July 28, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)